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Serialization Consultant - Packaging Framingham United States,  

ESP (company)


Posted on : 10 July 2017

Project Description

Description:
Are you an Packaging Engineer with experience in Serialization in the Life Sciences industry?  This role offers an opportunity to further develop your skill set working with leading global life science companies in an area undergoing rapid technical advancement with opportunities for significant career development. 


RESPONSIBILITIES
  • Contribute to the generation & execution of various program & GMP related documents and protocols, including a number of the following: validation master plan, URS, FRS/DS, traceability matrix, test specs, IQ, OQ, Integrated OQ & PQ, relevant summary reports and change controls 
  • Lead the design in all areas of technology and integration including operating philosophy, URS, FDS, DDS and configuration 
  • Approval of design specifications for new equipment and systems 
  • Management of system vendors (including equipment vendors with automation systems in their scope) 
  • Execution of FAT s / SAT s 
  • Support testing, validation and qualification of new equipment and systems as required 
  • Contribute to rollout in the areas of SOP review, training, cutover scheduling and interface with the business 
  • On-going support for project specific installations including equipment, systems and operational issues 
  • Development of training plans for new equipment introduced to site 
  • Generation of detailed project schedules 
  • Project change control implementation in accordance with requirements, design and system changes 
  • Identify risks and clearly communicate them to project stakeholders 
  • Support completion of work-stream activities 
 

REQUIREMENTS
  • BS or MS in Engineering, Life Sciences, or IT is preferred 
  • Must have 7+ years of relevant industry experience 
  • Familiar with ISA 95 
  • Previously worked as a line support engineer, project engineer or automation engineer in an FDA regulated packaging plant 
  • Must have previous experience with barcoding, printing, vision systems and packaging control systems integration 
  • Experience across a range of packaging forms including primary, secondary and tertiary packaging 
  • Previous serialization or track & trace project experience is highly advantageous 
  • Understanding of packaging processes, warehouse and distribution streams 
  • Knowledge of applicable standards relating to serialization e.g. GS1, EPCGlobal etc. 
  • Previous systems experience in a GMP / FDA regulated environment is essential. 
  • Exposure to any of the following systems is highly desirable: 
  • Integrated packaging hall control systems (Antares Vision, Systech, Laetus, Seidenader etc.) 
  • MES (Werum, Rockwell PMX or Pharm Suite, Honeywell POMS, XFP etc.) 
  • ERP (SAP, Oracle, etc.) 
  • EPCIS (SAP Aii OER, Axway, Oracle, Tracelink etc.) 
  • Previous experience working as part of a large, multi-disciplinary team completing full project life-cycle implementations 

Locations

Framingham MA

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